Clinical trial

A Feasibility Study of a Novel mHealth Clinical Decision Support Application to Enable Community Health Workers to Manage Hypertension With Remote Physician Supervision

Name

2022-0794

Description

This is a single group study assessing the feasibility of hypertension management by community health workers (CHWs) equipped with a mobile clinical decision support (CDS) application and working with remote physician supervision.

Trial arms

Trial start

2023-02-06

Estimated PCD

2023-08-15

Trial end

2024-12-30

Status

Active (not recruiting)

Treatment

Anti-Hypertensive

Based on information entered by the CHWs into the CommCare application designed for this study, the application will provide recommendations (and underlying rationale for these recommendations) for prescription of antihypertensives (amlodipine and/or losartan OR enalapril) and medications to reduce cardiovascular risk (aspirin and atorvastatin) if indicated, lifestyle modification, and referral to the supervising physician if indicated for potential complications of hypertension.

Size

Primary endpoint

Change in systolic blood pressure

baseline, 6 months

Difference in diastolic blood pressure from baseline to 6 months

baseline, 6 months

Change in the proportion of patients with systolic blood pressure less than or equal to 140

baseline, 6 months

Change in the proportion of patients with systolic blood pressure less than or equal to personalized goal

baseline, 6 months

Proportion of visits for which both the CHW conducting the visit and the physician reviewing post-visit data agreed with the antihypertensive recommendations provided by the CDS application

Up to 12 months

Eligibility criteria

Inclusion Criteria: * Greater than 18 years old * Diagnosed with hypertension * Blood pressure greater than or equal to 140/90 mm Hg OR * currently taking antihypertensive medication Exclusion Criteria: * Pregnancy * Severe comorbid condition(s) with life expectancy less than 1 year

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}

Updated at

2024-02-22

1 organization

1 product

1 indication

Organization

University of Wisconsin, Madison

Product

Anti-Hypertensive

Indication

Hypertension